Growth Disorders Clinical Trial
Official title:
Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Mexico
This is a Mexican, Multicentre, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.
Subjects will be enrolled in a multicenter longitudinal observational study. Parents and
patients will provide their Informed Consent to upload their data for population-based
analyses and optionally to adhere to a patient adherence support program "AUMENTA" designed
to improve their adherence and, ultimately, clinical outcomes. Adherence data will be
primarily derived from the easypod™ device combined with physician data entry of outcome
measures. Data will be collected retrospectively and prospectively. This will allow the
establishment of adherence profiles and explore the hypothesis that patient adherence support
programs improve adherence and subsequent clinical outcomes. Collected data will be also
analyzed in a multinational pooled analysis of comparable national studies.
Primary Objective:
-To assess the level of adherence of subjects receiving SAIZEN® via easypod™
Secondary Objectives:
- To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
via easypod™
- To identify adherence subject profiling
- To asses the impact of adherence on IGF1 (i.e. above, below or within normal ranges)
- To assess/describe the impact of Mexico patient support program "AUMENTA"
;
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